Health BehaviorPhase 1NCT05745870
Creatine Supplementation and Resistance Training in Premenopausal Females
A Phase 1 study testing Creatine Monohydrate Supplementation in people with Health Behavior, run by University of Idaho at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the effects of creatine monohydrate and resistance training on lean mass, sleep, muscular strength, and perceived menstrual cycle symptoms in untrained premenopausal females. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Creatine Monohydrate Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 12 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal females 18-25 yrs
- able to resistance train with no contraindications to exercise testing
Who cannot join
- premenopausal female taking hormonal contraceptives
- premenopausal females who are resistance training >2x/wk
- premenopausal females who consume creatine monohydrate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Creatine Supplementation and Resistance Training on Lean Mass, Sleep, Muscular Strength, and Perceived Menstrual Cycle Symptoms in Premenopausal Females
The goal of this clinical trial is to determine the effects of creatine monohydrate and resistance training on lean mass, sleep, muscular strength, and perceived menstrual cycle symptoms in untrained premenopausal females. The main questions it aims to answer are: 1) Does creatine monohydrate supplementation improve body composition, muscular strength, and sleep? 2) Does creatine monohydrate decrease perceived menstrual cycle symptoms compared to a placebo control?
Participants will be asked to consume creatine monohydrate daily for 42 consecutive days and well as perform a daily ovulation test. Pre and post testing will include assessments of urine specific gravity to determine hydration status, body composition testing, muscular strength testing and questionnaires.
Researchers will compare creatine monohydrate supplementation to a maltodextrin control to see if body composition, sleep, muscular strength, and perceived menstrual cycle symptoms are improved following 6-weeks.
Read the detailed description
This study will be a 6 week creatine monohydrate and resistance training intervention with performance familiarization and pre and post testing. Participants will report to the Human Performance Laboratory (HPL), having fasted from alcohol, caffeine, and exercise for a minimum of 12-hours, for pre testing and to sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then provide one urine sample to determine proper hydration status for body composition assessment. Next, participants will complete a physical activity readiness questionnaire (PARQ+) prior to performing any physical tasks. Participants will complete a daily menstrual cycle log, fatigue questionnaire, and health history survey. Prior to body composition testing, participants will complete a dual-energy x-ray apsorptiometry (DXA) scan consent for to ensure absence of pregnancy. Then, a full-body DXA scan will be completed along with an InBody bioelectrical impedance analysis. Following body composition testing, participants will be fitted for an Oura ring to track their sleep. Lastly, muscular strength will be assessed using the Tonal. Following a 5-minute full-body warm up, 1-repetition maximum will be determined using two upper body and two lower body exercises at maximal effort. Upon conclusion of pre-testing, participants will be randomized into two groups: 1) creatine monohydrate (5g/d creatine monohydrate + 5g/d maltodextrin) or 2) placebo (10 g/d maltodextrin) for 42 consecutive days. Participants will visit the HPL daily to consume their respective supplement as well as provide a urine sample for ovulation status determination. Additionally, participants will complete two resistance training sessions on non-consecutive days using the Tonal per week for 6-weeks. Following 6-weeks, post-testing will occur and includes the same procedures as pre-testing.
- Conditions
- Health Behavior
- Being tested
- Creatine Monohydrate Supplementation
- Keywords
- Creatine monohydrate, resistance training, menstrual cycle, female physiology, body composition
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine Monohydrate SupplementationDietary supplement
Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate Supplementation | Experimental | Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days Receives: Dietary Supplement: Creatine Monohydrate Supplementation |
| Placebo Supplementation | Placebo comparator | Participants will consume 10g/d maltodextrin for 42 consecutive days Receives: Dietary Supplement: Creatine Monohydrate Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Change in lean mass (kg, %) using a DXA scan from baseline after 42 days
Measured: 42 days
Sleep
Change in sleep (hours, minutes, REM) using the Oura Ring application tracking from baseline after 42 days
Measured: 42 days
Muscular Strength
Change in muscular strength (1-repetition maximum) using the Tonal from baseline after 42 days
Measured: 42 days
Perceived Menstrual Cycle Symptoms
Change in perceived menstrual cycle symptoms (fatigue, cramping, bloating) using menstrual cycle questionnaires from baseline after 42 days
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Jan 2023
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Brown, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745870
- Sponsor's protocol ID
- 21-170
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation and Resistance Training on Lean Mass, Sleep, Muscular Strength, and Perceived Menstrual Cycle Symptoms in Premenopausal Females
- ClinicalTrials.gov ID
- NCT05745870
- Acronym / sponsor ID
- 21-170
- Conditions
- Health Behavior
- Keywords
- Creatine monohydrate, resistance training, menstrual cycle, female physiology, body composition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the effects of creatine monohydrate and resistance training on lean mass, sleep, muscular strength, and perceived menstrual cycle symptoms in untrained premenopausal females. The main questions it aims to answer are: 1) Does creatine monohydrate supplementation improve body composition, muscular strength, and sleep? 2) Does creatine monohydrate decrease perceived menstrual cycle symptoms compared to a placebo control?
Participants will be asked to consume creatine monohydrate daily for 42 consecutive days and well as perform a daily ovulation test. Pre and post testing will include assessments of urine specific gravity to determine hydration status, body composition testing, muscular strength testing and questionnaires.
Researchers will compare creatine monohydrate supplementation to a maltodextrin control to see if body composition, sleep, muscular strength, and perceived menstrual cycle symptoms are improved following 6-weeks.
Detailed description
This study will be a 6 week creatine monohydrate and resistance training intervention with performance familiarization and pre and post testing. Participants will report to the Human Performance Laboratory (HPL), having fasted from alcohol, caffeine, and exercise for a minimum of 12-hours, for pre testing and to sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then provide one urine sample to determine proper hydration status for body composition assessment. Next, participants will complete a physical activity readiness questionnaire (PARQ+) prior to performing any physical tasks. Participants will complete a daily menstrual cycle log, fatigue questionnaire, and health history survey. Prior to body composition testing, participants will complete a dual-energy x-ray apsorptiometry (DXA) scan consent for to ensure absence of pregnancy. Then, a full-body DXA scan will be completed along with an InBody bioelectrical impedance analysis. Following body composition testing, participants will be fitted for an Oura ring to track their sleep. Lastly, muscular strength will be assessed using the Tonal. Following a 5-minute full-body warm up, 1-repetition maximum will be determined using two upper body and two lower body exercises at maximal effort. Upon conclusion of pre-testing, participants will be randomized into two groups: 1) creatine monohydrate (5g/d creatine monohydrate + 5g/d maltodextrin) or 2) placebo (10 g/d maltodextrin) for 42 consecutive days. Participants will visit the HPL daily to consume their respective supplement as well as provide a urine sample for ovulation status determination. Additionally, participants will complete two resistance training sessions on non-consecutive days using the Tonal per week for 6-weeks. Following 6-weeks, post-testing will occur and includes the same procedures as pre-testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate Supplementation | Experimental | Dietary Supplement: Creatine Monohydrate SupplementationParticipants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Creatine Monohydrate SupplementationParticipants will consume 10g/d maltodextrin for 42 consecutive days |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- premenopausal females 18-25 yrs
- able to resistance train with no contraindications to exercise testing
Key exclusion criteria (3 listed)
- premenopausal female taking hormonal contraceptives
- premenopausal females who are resistance training >2x/wk
- premenopausal females who consume creatine monohydrate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine Monohydrate SupplementationParticipants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days | Dietary supplement | Creatine Monohydrate Supplementation, Placebo Supplementation |
Primary outcome
Body Composition
Time frame: 42 days
Change in lean mass (kg, %) using a DXA scan from baseline after 42 days
Sleep
Time frame: 42 days
Change in sleep (hours, minutes, REM) using the Oura Ring application tracking from baseline after 42 days
Muscular Strength
Time frame: 42 days
Change in muscular strength (1-repetition maximum) using the Tonal from baseline after 42 days
Perceived Menstrual Cycle Symptoms
Time frame: 42 days
Change in perceived menstrual cycle symptoms (fatigue, cramping, bloating) using menstrual cycle questionnaires from baseline after 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Creatine Monohydrate Supplementation in people with Health Behavior, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 42 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.